Executive Director, Quality Control

Soufflé Therapeutics | Executive Director, Quality Control | Job Description

Soufflé Therapeutics is a biotech company focusing on the cell-type specific delivery of genetic medicines. It's team of driven scientists is making a mark in delivery of oligonucleotides to extrahepatic tissues. We thrive in a purpose-building lab and office space in Watertown. Come and join us in our quest!

Position Summary

The Executive Director, Quality Control (QC) will build and lead Soufflé's Quality Control function from the ground up: establishing the scalable processes, systems, and quality mindset needed to support a pipeline spanning monoclonal antibodies (mAbs), RNA therapeutics (mRNA, siRNA, ASOs), and oligonucleotide antibody conjugates.

In our virtual operating model, where testing, development, and manufacturing are outsourced to CDMOs/CROs, this is fundamentally a builder and cross-functional leadership role: you will design the governance frameworks, analytical strategy, and quality systems that scale with the company, rather than simply growing headcount.

Critical for this leader is a strong track record of building Quality Control organizations and processes, and partnering effectively across Regulatory, Manufacturing/CMC, Program Management, and external partners.

Key Responsibilities

Build & Scale the QC Function

• Design and implement scalable QC processes, systems, and governance frameworks appropriate for a virtual, outsourced operating model — prioritizing process and systems over headcount growth.
• Build a lean, high-functioning QC organization and instill a strong QC mindset across the company.

External QC Oversight

• Serve as the lead for external QC operations and provide oversight of QC testing at CDMOs/CROs.
• Drive external CDMO/CRO schedules to achieve overall project timelines.
• Lead tech transfers both between CDMO/CRO sites and between internal Analytical Development to our external partners.
• Evaluate vendors, method transfer, and comparability requirements as assays mature and as our vendor infrastructure advances to later clinical stages.
• Review partner QC deliverables, including method qualification protocols and data, CoAs, OOS/OOT investigations, and stability data to ensure appropriateness, accuracy and compliance.

Cross-Modality Analytical & QC Strategy

• Partner with Analytical Development to set overall QC technical strategy across antibody, RNA, and conjugate modalities including:
• Determine and evaluate phase-appropriate analytical test methods for IPCs and release tests that will meet regulatory expectations.
• Determine and evaluate phase-appropriate stability indicating assays that will meet regulatory expectations
• Guide modality-specific analytical approaches (e.g., glycan profiling, potency assays, RNA integrity/capping analysis, DAR characterization) executed by CDMO/CRO partners and internal SMEs.

Cross-Functional Leadership

• Partner closely with Regulatory Affairs, Manufacturing/CMC, Analytical Development, and Program Management to embed quality considerations early into study and program planning.
• Serve as the key cross-functional voice for QC deliverables and risk-based prioritization.

Regulatory Compliance

• Ensure QC activities align with cGMP, ICH, FDA, and EMA expectations.
• Primary author for QC sections of regulatory submissions.

Qualifications

• Proven track record building and scaling a QC function or quality organization, ideally within a virtual/outsourced biotech operating model.
• 12 years of QC experience across biologics and/or RNA modalities.
• 8 years leading QC operations and CDMO/CRO partnerships; early, career experience in analytical development and/or QC analytical testing is highly preferred
• Experience with either mAb, or siRNA are required
• Experience with the analytics of oligonucleotide antibody conjugates is preferred
• Strong cross-functional leadership skills, with experience partnering across Regulatory, Manufacturing, and Program teams.
• Experience operating in a cGMP environment required.

Additional Information

• Travel: ~20% to partner sites.

At Soufflé Therapeutics, we are intentional about building an equitable culture. How we treat our people is reflective of this focus. We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

This is an onsite position in Watertown, MA with flexibility as needed for collaboration and external engagements.